Optical Coherence Tomography Probe for Crossing Coronary Occlusions

ABSTRACT

Systems and methods for controlling a guide with the aid of optical coherence tomography (OCT) data are described. A guide wire includes at least one optical fiber, a flexible substrate, and one or more optical elements. The at least one optical fiber transmits a source beam of radiation. The flexible substrate includes a plurality of waveguides. At least one of the plurality of waveguides transmits one or more beams of radiation away from the guide wire, and at least one of the plurality of waveguides receives one or more beams of scattered radiation that have been reflected or scattered from a sample. The multiplexer generates the one or more beams of exposure radiation from the source beam of radiation. The one or more optical elements at least one of focus and steer the one or more beams of radiation.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Appl. No.62/035,301, filed Aug. 8, 2014, the disclosure of which is incorporatedby reference herein in its entirety.

BACKGROUND

1. Field

Embodiments of the invention relate to designs of, and methods of using,a guide wire and/or catheter together with optical tissue inspection.

2. Background

Coronary artery occlusion refers to the blockage of the blood flow inthe coronary artery. Occlusion may be partial or complete and it cancause serious complications: partial occlusion forces the heart to workharder and it may derive into angina whereas complete blockage may causeheart infarction or even death. These occlusions may be produced by agradual deposition of cholesterol and fatty materials around the wall ofthe coronary artery.

Partial occlusion may respond to pharmacological treatment (nitrates,calcium antagonists, etc.). In other cases, angioplasty may provide aneffective solution for the arterial occlusion. Angioplasty is apercutaneous method that provides a minimally invasive technique tomaintain blood flow in blocked arteries. The artery is mechanicallywidened by means of a balloon catheter. The tip of the catheter ispassed across the blockage and then, the balloon is inflated.Afterwards, a stent is usually inserted in the vessel acting as ascaffold at the position of the blockage to maintain blood flow.

Angiography is an x-ray based imaging technique typically used fornavigation of the balloon catheter or guide wire through the bloodvessels. It is used to visualize blood vessels by means ofradio-contrast agents. A less invasive approach is the magneticresonance angiography, although it requires more complex setups.

Angiography provides only limited information about the occlusionstructure and provides very little information about tissuecharacteristics. Current tools are unable to generate adequateinformation about the position of the guide-wire regarding the truelumen of the vessel.

BRIEF SUMMARY

In the embodiments presented herein, systems and methods for safelytraversing an occlusion using a guide wire or catheter are described.

In an embodiment, a catheter includes a distal section, a proximalsection, and a multiplexer. The distal section substantially surrounds aguide wire and includes a plurality of waveguides patterned upon aflexible substrate. At least one of the plurality of waveguidestransmits one or more beams of radiation away from the distal section ofthe catheter, and at least one of the plurality of waveguides receivesone or more beams of scattered radiation that have been reflected orscattered from a sample. The distal section also includes one or moreoptical elements that at least one of focus and steer the one or morebeams of radiation. The proximal section includes an optical source thatgenerates a source beam of radiation and a detector that generatesdepth-resolved optical data associated with the one or more beams ofscattered radiation. The multiplexer generates the one or more beams ofexposure radiation from the source beam of radiation.

In another embodiment, a guide wire includes at least one optical fiber,a flexible substrate, and one or more optical elements. The at least oneoptical fiber transmits a source beam of radiation. The flexiblesubstrate includes a plurality of waveguides. At least one of theplurality of waveguides transmits one or more beams of radiation awayfrom the guide wire, and at least one of the plurality of waveguidesreceives one or more beams of scattered radiation that have beenreflected or scattered from a sample. The multiplexer generates the oneor more beams of exposure radiation from the source beam of radiation.The one or more optical elements at least one of focus and steer the oneor more beams of radiation.

An example method is described. The method includes transmitting one ormore beams of radiation via one or more waveguides on a flexiblesubstrate within a guide wire and receiving one or more beams ofscattered or reflected radiation from a sample. The method furtherincludes generating, using a processing device, depth-resolved opticaldata of the sample based on the received one or more beams of scatteredor reflected radiation. The method includes determining at least one ofa distance between the guide wire and a wall of the artery and adistance between the guide wire and an occlusion within the artery basedon the depth-resolved optical data and controlling a position of theguide wire within the artery based on the determined distance ordistances.

BRIEF DESCRIPTION OF THE DRAWINGS/FIGURES

The accompanying drawings, which are incorporated herein and form a partof the specification, illustrate embodiments of the present inventionand, together with the description, further serve to explain theprinciples of the invention and to enable a person skilled in thepertinent art to make and use the invention.

FIG. 1 illustrates a catheter with a guide wire, according to anembodiment.

FIGS. 2A-2B illustrate elements within a guide wire, according toembodiments.

FIG. 3 displays optical elements arranged around a guide wire, accordingto an embodiment.

FIGS. 4A-4B display optical elements arranged within a catheter,according to embodiments.

FIG. 5 illustrates a block diagram of an interferometric system,according to an embodiment.

FIG. 6 illustrates interferometric scanning of an occlusion, accordingto an embodiment.

FIG. 7 displays an example ray-tracing simulation.

FIG. 8 displays simulation results of lateral resolution vs. field ofview of an image plane and an object plane, according to an embodiment.

FIG. 9 displays simulation results of depth of field vs. field of viewof an image plane and an object plane, according to an embodiment.

FIG. 10 displays simulation results of relative peak power vs. field ofview of an image plane and an object plane, according to an embodiment.

FIG. 11 displays simulation results of paraxial magnification vs. fieldof view of an image plane, according to an embodiment.

FIG. 12 depicts a method, according to an embodiment.

FIG. 13 illustrates an example computer system useful for implementingvarious embodiments.

Embodiments of the present invention will be described with reference tothe accompanying drawings.

DETAILED DESCRIPTION

Although specific configurations and arrangements are discussed, itshould be understood that this is done for illustrative purposes only. Aperson skilled in the pertinent art will recognize that otherconfigurations and arrangements can be used without departing from thespirit and scope of the present invention. It will be apparent to aperson skilled in the pertinent art that this invention can also beemployed in a variety of other applications.

It is noted that references in the specification to “one embodiment,”“an embodiment,” “an example embodiment,” etc., indicate that theembodiment described may include a particular feature, structure, orcharacteristic, but every embodiment may not necessarily include theparticular feature, structure, or characteristic. Moreover, such phrasesdo not necessarily refer to the same embodiment. Further, when aparticular feature, structure or characteristic is described inconnection with an embodiment, it would be within the knowledge of oneskilled in the art to effect such feature, structure or characteristicin connection with other embodiments whether or not explicitlydescribed.

It should be noted that although this application may refer specificallyto coronary occlusions, and the successful traversing of suchocclusions, the embodiments described herein may be used for any othersituations where a catheter or guide wire is guided through the body.

Described herein are embodiments of a catheter or guide wire fornavigating through a vessel, such as an artery. The navigation is aidedthrough the use of multiple view ports around the distal end of thecatheter or guide wire through which beams of radiation are transmittedand received from the surrounding tissue. The beams of radiation areguided by patterned waveguides and are included in an interferometricsystem. As described herein, the interferometric technique used isoptical coherence tomography (OCT). However, other interferometrictechniques can be used as well. The OCT data may be used to generateimages of the surrounding tissue and any occlusions blocking the pathfor the guide wire to travel. The data may also provide distanceinformation between the guide wire and tissue and/or occlusion. Thisdistance information may be utilized by a user or automatic feedbacksystem to keep the guide wire or catheter substantially centered in theartery as it moves within the artery.

In one embodiment, the OCT data of the occlusion may be used todetermine the location of one or more microchannels through theocclusion. The guide wire or catheter may be guided through theocclusion based on the locations of the microchannels. For example, themicrochannels may indicate areas of the occlusion that are weaker andeasier to puncture with the guide wire.

Herein, the terms “electromagnetic radiation,” “light,” and “beam ofradiation” are all used to describe the same electromagnetic signalspropagating through the various described elements and systems.

General Catheter Design

FIG. 1 illustrates a catheter 100 according to an embodiment. Catheter100 includes a proximal part 102, a distal part 104, and a sheath 106coupled between proximal part 102 and distal part 104. In an embodiment,sheath 106 includes one or more radiopaque markers for navigationpurposes. In one embodiment, catheter 100 includes a communicationinterface 110 between catheter 100 and a processing device 108.Communication interface 110 may include one or more wires betweenprocessing device 108 and catheter 100. In other examples, communicationinterface 110 is an interface component that allows wirelesscommunication, such as Bluetooth, WiFi, cellular, etc. Communicationinterface 110 may communicate with one or more transceiver elementslocated within either proximal part 102 or distal part 104 of catheter100.

In an embodiment, sheath 106 and distal part 104 are disposable. Assuch, proximal part 102 may be reused by attaching a new sheath 106 andproximal part 104 each time a new procedure is to be performed. Inanother embodiment, proximal part 102 is also disposable.

Proximal part 102 may house various electrical and optical componentsused in the operation of catheter 100. For example, a power supply maybe included within proximal part 102 to supply electrical signals tovarious elements located in either proximal part 102 or distal part 104.As such, one or more conductive wires (or any electrical transmissionmedium) may lead from the power supply to distal part 104 within sheath106. Furthermore, proximal part 102 may include an optical source forgenerating a beam of radiation. The optical source may include one ormore laser diodes or light emitting diodes (LEDs). The beam of radiationgenerated by the optical source may have a wavelength within theinfrared range. In one example, the beam of radiation has a centralwavelength of 1.3 μm. The optical source may be designed to output abeam of radiation at only a single wavelength, or it may be a sweptsource and be designed to output a range of different wavelengths. Thegenerated beam of radiation may be guided towards distal part 104 via anoptical transmission medium connected between proximal part 102 anddistal part 104 within sheath 106. Some examples of optical transmissionmedia include single mode and multimode optical fibers and integratedoptical waveguides. In one embodiment, the electrical transmissionmedium and the optical transmission medium are provided by the samehybrid medium allowing for both electrical and optical signalpropagation.

In an embodiment, proximal part 102 includes one or more components ofan interferometer in order to perform OCT using the light generated fromthe optical source. Further details of an interferometer system arediscussed with reference to FIG. 5. Due to the nature of interferometricdata analysis, in an embodiment the optical transmission medium used forguiding the light to and from distal end 104 does not affect the stateand degree of light polarization. In another embodiment, the opticaltransmission medium affects the polarization in a constant andreversible way.

In an embodiment, a guide wire 112 extends from distal part 104 ofcatheter 100. Guide wire 112 may be used to help navigate catheter 100through smaller vessels. According to various embodiments herein,optical elements may be placed in distal part 104 of catheter 100,and/or within a distal section of guide wire 112 for performing OCTanalysis of the surrounding tissue.

Proximal part 102 may include further interface elements with which auser of catheter 100 can control the operation of catheter 100. Forexample, proximal part 102 may include a deflection control mechanismthat controls a deflection angle of distal part 104 or of guide wire112. The deflection control mechanism may require a mechanical movementof an element on proximal part 102, or the deflection control mechanismmay use electrical connections to control the movement of distal part104 or guide wire 112. Proximal part 102 may include various buttons orswitches that allow a user to control when optical data is acquired fromdistal end 104 and/or guide wire 112.

Guide Wire OCT Embodiments

FIGS. 2A and 2B illustrate an embodiment of a guide wire 200 thatincludes optical elements near a tip of guide wire 200. FIG. 2Aillustrates various elements integrated at a distal end of guide wire200 and encapsulated within a housing. FIG. 2B illustrates a moredetailed example of the integrated elements without the housing. In oneexample, guide wire 200 includes one or more cutting lips 202 at itstip. Cutting lips 202 may be used to help guide wire 200 slice throughan occlusion that blocks the path of guide wire 200 within an artery. Inanother example, guide wire 200 includes a conical drill shape at itstip. Within guide wire 200, a multiplexing unit 204 is included andcoupled to light received from optical fiber 215, according to anembodiment. Optical fiber 215 transmits source light generated from anoptical source, and may also be designed to receive light collected fromaround guide wire 200. Other optical fibers may be included as well fortransmitting and/or receiving light, such as in a bundle of fibers.

According to an embodiment, optical fiber 215 is single-mode for theoperation wavelength. Due to the highly scattering nature of tissuescommonly involved when using a guide wire to navigate through bloodvessels, the operation wavelength may be centered at 1.3 micrometersbecause of reduced scattering. Depending on the application, otheroperation wavelengths may include 800 nm or 1050 nm. Optical fiber 215may include reduced cladding (80 μm) in order to minimize its diameterand to minimize the acceptable bend radius of optical fiber 215.

Multiplexing unit 204 may include an input waveguide 216 for receivinglight guided from optical fiber 215. A molded element 206 may beprovided to help align optical fiber 215 with input waveguide 216 ofmultiplexing unit 204. Multiplexing unit 204 provides one or more beamsof radiation to a plurality of waveguides 218 that are used to transmitlight in a forward-looking direction of guide wire 200, according to anembodiment. This forward-looking direction may be substantially parallelto an axis extending along a length of the guide wire and passingthrough a center of the guide wire. Plurality of waveguides 218 may bepatterned or otherwise provided on a flexible substrate. The flexiblesubstrate may be rolled into a particular shape to fit within the tightconfines of guide wire 200. For example, the flexible substrate thatincludes plurality of waveguides 218 may be rolled into an annulusshape. Plurality of waveguides 218 may provide multiple scanning beamsof light for performing OCT in front of guide wire 200. In one example,a substantially straight scanning line 216 is created based on lightoutputs from plurality of waveguides 218 through a machined opening 210at the tip of guide wire 200. Plurality of waveguides 218 may be equallyspaced apart from one another. For example, each of plurality ofwaveguides 218 may be spaced 50 μm from one another. In an embodiment,one or more optical elements 208 are included between plurality ofwaveguides 218 and opening 210. Optical elements 208 may include anynumber of mirrors and/or modulators used to at least one of focus andsteer the beam of light. In one example, optical elements 208 includes agraded index refraction (GRIN) lens.

In one embodiment, a side-imaging waveguide 220 is included in order totransmit and/or collect beams of radiation from different angles aroundguide wire 200. For example, side-imaging waveguide 220 may direct abeam of radiation towards a reflector 222. Reflector 222 directs thebeam of light through an imaging port 212 and away from guide wire 200.The beam of light may be transmitted at a non-zero angle relative to anaxis extending along a length of the guide wire and passing through acenter of the guide wire. Scattered or reflected light can also bereceived through imaging port 212. In this way, lateral imaging oftissue surrounding guide wire 200 can be achieved. More than one imagingport 212 and side-imaging waveguide 220 can be included within guidewire 200 to take OCT images at various angles. Plurality of waveguides218 provide imaging capability of tissue directly in front of guide wire200, according to an embodiment.

According to an embodiment, at least one of plurality of waveguides 218transmits a beam of radiation away from guide wire 200 and at least oneof plurality of waveguides 218 receives a beam of scattered and/orreflected radiation from a sample.

Multiplexing unit 204 may include associated electronics that providecontrol signals to various modulating elements of multiplexing unit 204in order to direct light through various waveguides such as side-imagingwaveguide 220 and plurality of waveguides 218. Multiplexing unit 204 mayuse any multiplexing method that allows for the separation ofcontributions from the light collected around guide wire 200. One suchmultiplexing method is time-domain multiplexing, in which multiplexingunit 204 switches between different output waveguides in a controlledmanner, so that at a given time only one associated waveguide is active.Another suitable multiplexing method is frequency-domain multiplexing,in which light traversing each of the waveguides is modulated in such away that the time-frequency behavior of signals corresponding todifferent waveguides can be differentiated by a processing device.Coherence-domain multiplexing may also be used in multiplexing unit 204,by introducing a different group delay to the light traversing eachwaveguide, so that the signals corresponding to different waveguidesappear at different coherence positions and can be thereforedifferentiated by a processing device. In an embodiment, these methodsare non-exclusive and can be combined in order to find the best designcompromise. Based on the multiplexing method used, multiplexing unit 204may be a passive element or electrically driven. Some of themultiplexing methods, like coherence-domain multiplexing, do not requireany electrical actuation of multiplexing unit 204. Thus, in anembodiment, implementations based on coherence-domain multiplexing donot require electrical transmission media for control signals.

In one embodiment, multiplexing unit 204 is produced on a siliconphotonics optical chip using a network of thermo-electric opticalswitches. Other suitable materials for use in multiplexing unit 204include, for example and without limitation, silicon nitride, silicondioxide, oxinitride, lithium niobate, III-V semiconductor materials,silicon carbide and optical grade polymers. Other modulation effects tosupport the optical switching operation include the electro-opticeffect, charge carrier density effects, photo-mechanical effects, liquidcrystal based refractive index modulation, etc. The multiplexingfunction may also be obtained through microelectromechanical (MEMS)devices in as far as miniaturization and packaging constraints can bemet.

In an embodiment, multiplexing unit 204 is fabricated upon a flexiblesubstrate. Multiplexing unit 204 may be fabricated on a same flexiblesubstrate as plurality of waveguides 218. A process for forming theoptical elements upon a flexible substrate includes a substrate transferpost-processing step applied to Silicon on Insulator (SOI) chips orwafers, as described in more detail in U.S. Pat. No. 9,062,960, thedisclosure of which is incorporated by reference herein in its entirety.In an embodiment, the resulting flexible device is thinner (<100 μm)than the starting thickness (500-700 μm). Multiplexing unit 204 may beimplemented by an optical integrated chip that is partly flexible.

In an embodiment, guide wire 200 includes a braided coil 214 leading upto the various optical elements disposed near the tip. Braided coil 214may be designed to transmit torque during a rotation of guide wire 200.Rotating guide wire 200 may be helpful for providing a complete imagearound guide wire 200. The rotation also will rotate the forward-lookingradiation beams to provide a wider view of a sample surface in front ofguide wire 200 as illustrated in FIG. 2A. Rotation of guide wire 200 maybe performed manually by an operator, or by electrically drivenactuators. Upon controlled rotation, the forward-facing opening 210 canbe used to sample a 3D volume in front of the tip of guide wire 200,while imaging port 212 provides a rotational scan showing the relativeposition of guide-wire 200 within an artery, according to an embodiment.

During rotation, guide wire 200 may accumulate strain. If rotation iskept at a constant frequency, fatigue can be minimized while rotation ofthe tip reaches steady state after a few turns. To monitor torsionalloads, one or more strain gauges may be included on guide wire 200.Thus, by combining an appropriate model of strain accumulation and thefeedback obtained from strain gauges, appropriate location of thevarious beams of radiation transmitted from guide wire 200 can beachieved within a 3D model. Other solutions enabling torsion monitoringby optical means can be exploited. In an embodiment, the use ofdistributed Fiber Bragg Gratings (FBGs) defined along optical fiber 215allows for sensing the stress along guide wire 200 if both optical fiber215 and guide wire 200 are in conjunction. The distributed strainsensors may be interrogated at wavelengths different from that used bythe OCT system, thus avoiding optical crosstalk. Alternatively, guidewire 200 may be supported by a catheter with a steerable tip which wouldassist in navigation through tortuous vascularity. This catheter may beprovided with OCT capabilities as well, and is described herein.

Catheter OCT Embodiments

FIG. 3 illustrates a view of catheter 300, according to an embodiment.Catheter 300 includes elements involved in the transmission of radiationfor imaging around catheter 300. Catheter 300 also substantiallysurrounds a guide wire 302 that passes through a center axis of catheter300. Note that a housing which would contain the various opticalelements is not included in FIG. 3 for clarity.

According to an embodiment, catheter 300 includes a distal sectionhaving a waveguide input 304, a multiplexing unit 306, a flexiblesubstrate 308 that includes a plurality of waveguides 310, and aplurality of optical elements 312. One or more optical elements 312 maybe included within a molded element 314 to substantially align one ormore optical elements 312 with outputs from plurality of waveguides 310.Each individual element of one or more optical elements 312 may bedesigned to feature a different optical performance. For example,properties such as the depth of field (DoF), resolution, workingdistance (WD), and beam direction (e.g., beam steering) can bediscretely adjusted for each optical element. Other optical elements,such as lenses, mirrors, etc. may be included as well without deviatingfrom the scope or spirit of the invention.

Each of the elements included within catheter 300 may operate in asimilar fashion to corresponding elements previously described as beingincluded within a guide wire. For example, waveguide input 304 may besimilar to optical fiber 215, multiplexing unit 306 may be similar tomultiplexing unit 204, plurality of waveguides 310 may be similar toplurality of waveguides 218, and one or more optical elements 312 may besimilar to one or more optical elements 208. As can be seen from theillustration in FIG. 3, both multiplexing unit 306 and flexiblesubstrate 308 may be wrapped in an annulus shape substantially aroundguide wire 302. Plurality of waveguides 310 may guide beams of radiationvia one or more optical elements 312 in a forward-looking direction asguide wire 302 moves through a vessel, such as an artery.

According to an embodiment, at least one of plurality of waveguides 310transmits a beam of radiation away from catheter 300 and at least one ofplurality of waveguides 310 receives a beam of scattered and/orreflected radiation from a sample.

Catheter 300 may be used to deliver stents which act as scaffolds tomaintain blood flow through blocked blood vessels. To maximize couplingefficiency between waveguide input 304 and multiplexing unit 306,focusing optics may be used. The focusing optics may be included on theflexible substrate of multiplexing unit 306 or could be their ownelements spaced between waveguide input 304 and multiplexing unit 306.Alternatively, lensed optical fibers can provide a more compact solutionproviding mode matching between an input/output waveguide patterned on aflexible substrate and the light propagating medium without the use ofextra optical elements. Similar to the guide wire embodiments discussedpreviously, multiple view-ports may be implemented by making use ofvarious waveguides to direct light at different angles from catheter300. In one example, a micro-optics-based lens array can be included fortransmitting and receiving beams of radiation from various view portsaround catheter 300. The optical performance of each focusing elementincluded in the array may be independently designed in order to adjustangle of incidence, depth of focus and lateral resolution among others.

FIGS. 4A and 4B illustrate a side view and front-facing viewrespectively of catheter 300, according to an embodiment. The side viewillustrated in FIG. 4A shows how guide wire 302 may protrude out furtherfrom the distal end of catheter 300. Catheter 300 is also shown toinclude an optical fiber 402 coupled to some kind of waveguide as partof multiplexing unit 306. Multiplexing unit 306 may be designed toreceive a beam of radiation from optical fiber 402 and provide multiplebeams of radiation to be guided via plurality of waveguides 310. FIG. 4Billustrates how optical fiber 402 may couple to one portion ofmultiplexing unit 306. Multiplexing unit 306 is illustrated as wrappedin an annulus shape within catheter 300 and substantially around guidewire 302.

In one embodiment, the elements used to provide OCT imaging aroundcatheter 300 and guide wire 302 are only contained within catheter 300.In another embodiment, the elements used to provide OCT imaging aroundcatheter 300 and guide wire 302 are only contained within guide wire302. In another embodiment, the elements used to provide OCT imagingaround catheter 300 and guide wire 302 are contained within bothcatheter 300 and guide wire 302.

In an embodiment, flexible electronics can be used to facilitateelectrical driving of multiplexing unit 306. In one example, a printedcircuit board (PCB) may include the necessary driving electronics and beattached to a photonic integrated chip (PIC), by means of, for example,flip chip technology. Both the PCB and PIC may then be subjected to aflexibilization process, resulting in a rolled stack of materials asillustrated generally in FIG. 3, where multiplexing unit 306 andflexible substrate 308 are coupled together. In this embodiment, alensed fiber may be used as waveguide input 304 to couple light in andout. In one embodiment, a hybrid cable containing the aforementionedlensed fiber and electrical wires propagating the signals drivingmultiplexing unit 306 is used. In other embodiment, both the lensedfiber (or any other light transmission media such as flexible planarlightwave circuits (PLCs)) and the electrical wires are assembledseparately. For clarifying purposes, the array is separated from theoutput of the flexible chip. However, it may be attached to the outputwaveguides of the flexible PIC in a manner as known to one of skill inthe art. In other embodiments, different types of focusing opticssolutions can be used. Note that for simplicity, the micro-cathetersheath is not shown in FIG. 4.

Interferometry System Embodiment

Various embodiments of the present application include an OCT-basedimaging system for optical interrogation of tissue. FIG. 5 illustratesan example OCT system 501 for imaging a sample 510, according to anembodiment. For example, sample 510 may be a portion of an atrial wall.A delay unit 512 may include various light modulating elements. Thesemodulating elements may perform phase and/or frequency modulation tocounteract undesired optical effects in the light, and to select one ormore depths of sample 510 to be imaged. The use of the term “light” mayrefer to any range of the electromagnetic spectrum. In an embodiment,the term “light” refers to infrared radiation at a wavelength of about1.3 μm.

OCT system 501 further includes an optical source 502, a splittingelement 504, a sample arm 506, a reference arm 508, and a detector 514.In the embodiment shown, delay unit 512 is located within reference arm508. However, it should be understood that delay unit 512 may instead belocated in sample arm 506. Alternatively, various elements of delay unit512 may be present in both sample arm 506 and reference arm 508. Forexample, elements of delay unit 512 that introduce a variable delay tothe light may be located in sample arm 506, while elements that modulatedifferent polarization modes of the light may be located in referencearm 508. In one example, sample arm 506 and reference arm 508 areoptical waveguides, such as patterned waveguides or optical fibers. Inan embodiment, all of the components of OCT system 501 are integratedonto a planar lightwave circuit (PLC). In another embodiment, at leastthe components within delay unit 512 are integrated on the samesubstrate of a PLC. Other implementations may be considered as well,such as, for example, fiber optic systems, free-space optical systems,photonic crystal systems, etc. The various optical components, such assplitting element 504, sample arm 506, reference arm 508, and delay unit512, may be integrated on the same substrate as the multiplexing unitdescribed previously in either the catheter or guide wire embodiments.In another embodiment, such optical elements are integrated on their ownsubstrate and may be included anywhere within catheter 100.

It should be understood that OCT system 501 may include any number ofother optical elements not shown for the sake of clarity. For example,OCT system 501 may include mirrors, lenses, gratings, splitters,micromechanical elements, etc., along the paths of sample arm 506 orreference arm 508.

Splitting element 504 is used to direct light received from opticalsource 502 to both sample arm 506 and reference arm 508. Splittingelement 504 may be, for example, a bi-directional coupler, an opticalsplitter, or any other modulating optical device that converts a singlebeam of light into two or more beams of light.

Light that travels down sample arm 506 ultimately impinges upon sample510. Sample 510 may be any suitable sample to be imaged, such as tissue.The light scatters and reflects back from various depths within sample510, and the scattered/reflected radiation is collected back into samplearm 506. In another embodiment, the scattered/reflected radiation iscollected back into a different waveguide than the transmittingwaveguide. The scan depth may be chosen via the delay imposed on thelight within delay unit 512. In an embodiment, sample arm 506 isimplemented as optical fiber 215 from the above-described guide wireembodiment and/or as optical fiber 402 from the above-described catheterembodiment.

Light within sample arm 506 and reference arm 508 is recombined beforebeing received at detector 514. In the embodiment shown, the light isrecombined by splitting element 504. In another embodiment, the light isrecombined at a different optical coupling element than splittingelement 504. Detector 514 may include any number of photodiodes,charge-coupling devices, and/or CMOS structures to transduce thereceived light into an electrical signal. The electrical signal containsdepth-resolved optical data related to sample 510 and may be received bya processing device for further analysis and signal processingprocedures. As used herein, the term “depth-resolved” defines data inwhich one or more portions of the data related to specific depths of animaged sample can be identified.

In an embodiment, optical source 502, detector 514 and delay unit 512are located within proximal part 102 of catheter 100. Splitting element504 and at least part of one or both of sample arm 506 and reference arm508 may be located in either proximal part 102 or distal part 104 ofcatheter 100. In another embodiment, all of the elements of OCT system501 are located in distal part 104 of catheter 100. Optical source 502may include one or more light emitting diodes (LEDs) or laser diodes.For example, LEDs may be used when performing time domain and/orspectral domain analysis, while tunable lasers may be used to sweep thewavelength of the light across a range of wavelengths.

OCT system 501 is illustrated as an interferometer design similar to aMichelson interferometer, according to an embodiment. However, otherinterferometer designs are possible as well, including Mach-Zehnder orMireau interferometer designs.

Imaging Technique Embodiments

FIG. 6 illustrates the use of OCT imaging around a catheter and guidewire system to aid in the navigation of the catheter and guide wirethrough a vessel, according to an embodiment. As an example, FIG. 6illustrates an arterial wall 610 and an occlusion 612 blocking the pathof catheter 602 and guide wire 604.

Multiple OCT scans based on transmitting a beam of radiation andreceiving scattered and/or reflected beams of radiation from thesurrounding tissue are illustrated. For example, a plurality ofinterferometry scans 606 may emanate from a distal end of guide wire604. Plurality of interferometry scans 606 may be arranged such that astraight line of any sample in front of guide wire 604 is imaged. Inanother example, by arranging the angle of the looking-forwardinterferometry scans 606 appropriately, truncated cone images mayinterlace, thus increasing resolution by a factor of 2 after a rotationis made of guide wire 604. Guide wire 604 may be rotated about an axispassing through a center of guide wire 604, as illustrated in FIG. 6 anddescribed previously.

The rotation of guide wire 604 to gain 3D images of part of a volume infront of guide wire 604, and potentially 2D images of a portion ofarterial wall 610, can be introduced by a mechanical actuator placedoutside the body and in physical connection with a proximal end of guidewire 604. Such an actuator may be designed to produce a continuousrotation of guide wire 604 with at least 180 degrees range. If therotation speed is moderate (one or two images per second) and therotation is not free-running, but rather applied in a periodicoscillating way, a rotational coupler may be avoided at the distal endof guide wire 604. Transmission of the applied torque to the distal endof guide wire 604 may be considered since limited stiffness of the wiremay require a constant rotation direction.

Images are also captured of arterial wall 610, surrounding at least aportion of catheter 602 and/or guide wire 604. These images are achievedfrom additional interferometry scans 608 a-c extending at differentangles (e.g., right angles) from the main body of catheter 602 and guidewire 604. For example, guide wire 604 may perform interferometry scan608 c by directing light via a spherical reflector away from guide wire604 at a different angle than interferometry scans 606. Also, catheter602 may perform interferometry scans 608 a-b by directing light via oneor more spherical reflectors away from catheter 602 at a different anglethan interferometry scans 606. By rotating guide wire 604 (and catheter602) as illustrated in FIG. 6, images can be captured of a section ofarterial wall 610 that substantially surrounds catheter 602 and/or guidewire 604.

The OCT data that can be collected from any of interferometry scans 608a-c and 606 may be used to determine various distances and properties ofthe surrounding tissue, according to some embodiments. For example,interferometry scans 608 a-b may be used to determine a distance betweencatheter 602 and arterial wall 610, while interferometry scan 608 c maybe used to determine a distance between guide wire 604 and arterial wall610. An operator of catheter 602 may use the distance information tocontrol the placement of catheter 602 to substantially align within acenter of the artery as catheter 602 moves along a length of the artery.In another example, the distance information is used as a control signalin a feedback configuration to automatically control the position ofcatheter 602 within the artery.

The more forward-looking interferometry scans 606 may be used to gatherdistance and morphology information regarding occlusion 612, accordingto an embodiment. For example, the OCT data extracted frominterferometry scans 606 may be used to determine the presence ofmicro-channels present within occlusion 612. These micro-channels maypresent a path of least resistance for boring through occlusion 612 withguide wire 604.

Some biological polymers such as collagen are substantiallybirefringent. Collagen is particularly present in the tunica adventitiain the arterial wall, the outermost layer of blood vessels. Thus,polarization-sensitive imaging may be introduced to increase contrastbetween the imaged structures. In another example, blood may flow thoughany micro-channels present within occlusion 612, and therefore Dopplerimaging may contribute to enhance these micro-channel structures.

Optical Simulation Results

FIG. 7 illustrates a ray-tracing simulation of a plurality ofinterferometry scans originating from a device and propagating through amedium. The beams originate from waveguide output plane 702 and passthrough a lens 704, such as a GRIN lens. After traversing lens 704, thebeams propagate through medium 706 and impinge upon sample interface708. For the simulation illustrated, the refractive index of medium 706is set to 1.33 at a wavelength of 1.32 μm to model human blood. Also thedistances between various optical planes denoted as X₁, X₂, and X₃ areeach set to achieve Gaussian beam profiles at sample interface 708having a full width half maximum (FWHM) of about 21.9 μm (e.g., lateralresolution of about 22 μm.) In this simulation example, X₁=37 μm, X₂=534μm, and X₃=3.498 mm. The three ray traces originate at waveguide outputplane 702 and are spaced such that they are transmitted from waveguidesthat are 50 μm apart from one another.

As shown in the simulation, the working distance between the end of theguide wire and sample interface 708 is about 3.5 mm. A glass spacer maybe attached to an end of the guide wire to adjust the working distance.For example, it may be desirable to adjust the working distance to behalf of the depth of field (DOF).

FIGS. 8-11 provide further example simulation results of variousparameters based on the ray-tracing environment of FIG. 7. FIG. 8 showssimulation results for the lateral resolution (FWHM) as a function ofthe field of view (FOV) in the object plane (sample interface 708) andimage plane (X₁ distance from waveguide output plane 702), relative to acenter position. According to an embodiment, and as derived from theresults shown in FIG. 8, the larger the FOV on the image plane, thelower the lateral resolution. Therefore, a minimum lateral resolutionfigure will limit the FOV in practice. Assuming a maximum degradation of10% over the designed FWHM (24.09 μm), the FOV becomes approximately1.16 mm, which represents 0.1 mm in the image plane. Therefore, theoutput waveguides position should be properly distributed along ±0.05 mmfrom a center position in order to reach continuous scanning on theobject plane.

FIG. 9 shows the relationship between the DOF and the FOV in the objectplane and in the image plane. As illustrated in FIG. 9, at the centerposition of 21.9 μm, FWHM is obtained, which represents a DOF of 1.64mm. The loss of lateral resolution results in an enlargement of the DOF.Assuming a FOV on the object plane of 1.16 mm, the DOF becomes 2 mm inthe vicinity of the FOV limits.

FIG. 10 shows the relative peak power as a function of the FOV in theimage plane and the object plane. Results shown in FIG. 10 may beunderstood as an indicator of the beam distortion. The peak power isreduced when increasing the FOV because secondary lobules appear. Inthis case, the peak power is reduced by less than the 5% assuming a FOVof 1.16 mm in the object plane.

FIG. 11 shows the paraxial magnification as a function of the imageplane measured from the center position to the image plane limit.According to an embodiment, the paraxial magnification of a GRIN lensdoes not show a flat profile as a function of the field of view. Infact, the paraxial magnification stops being flat when considering a FOVon the image plane larger than 0.06 mm as depicted in FIG. 11. Thiseffect may be corrected under certain conditions by acting on theprofile of the refractive index of the GRIN lens.

Example Method of Operation

FIG. 12 illustrates an example method 1200 for controlling the positionof a guide wire. The guide wire may be within an artery and used to borethrough an occlusion within the artery. Method 1200 may be performed byvarious components of guide wire 200 and/or catheter 300 in conjunctionwith processing device 108.

At block 1202, one or more beams of radiation are transmitted away froma guide wire, according to an embodiment. The beams of radiation may betransmitted away using a plurality of waveguides patterned onto aflexible substrate. The waveguides may be arranged along with otheroptical elements to transmit the beams of radiation in a forward-facingdirection substantially parallel to an axis extending along a length ofthe guide wire and passing through a center of the guide wire. Some ofthe waveguides may be arranged to transmit beams of radiation atnon-zero angles with respect to the axis and away from the guide wire.

At block 1204, scattered or reflected radiation is received, accordingto an embodiment. This scattered radiation may be received by the sameplurality of waveguides used to transmit the beams of radiation, or bydifferent waveguides. The radiation may be scattered or reflected from asample around the guide wire.

At block 1206, depth-resolved optical data is generated based on thebeams of radiation received from the sample around the guide wire. Forexample, a detector may generate an electrical signal based on thereceived beams of radiation. The generated electrical signal may then bereceived by a processing device for further analysis and signalprocessing to perform certain actions and/or generate models based onthe depth-resolved optical data. An image of the sample surface, as wellas 3-D images through a depth of the sample, may be generated from thedepth-resolved optical data. The image may be provided to an operator ofthe guide wire via a user interface such as a display.

At block 1208, at least one distance is determined between the guidewire and the sample, according to an embodiment. This distance may beassociated with a distance to an arterial wall surrounding the guidewire, or to a distance between a front of the guide wire and anocclusion within the artery. The distance(s) may be determined based onthe depth-resolved optical data. The distances may be used to determinea relative location of the guide wire.

At block 1210, a position of the guide wire is controlled based on thedetermination, according to an embodiment. The distance information maybe relayed to an operator of the guide wire via any suitable userinterface (e.g., displace, audio cues, etc.) The operator may thencontrol the guide wire manually based on the distance information tokeep the guide wire centered within an artery. In another example, afeedback control system is used to automatically correct the position ofthe guide wire based on the distance information. The guide wire may becontrolled to maintain a position within a center of the artery as theguide wire moves along a length of the artery.

Many other actions may be performed as part of method 1200. For example,the guide wire may be controlled to traverse the occlusion in its pathusing one or more cutting lips disposed at the end of the guide wire. Inanother example, the guide wire may heat a portion of the occlusion toaid in passing through the occlusion. Heat may be generated by passing acurrent through one or more electrodes positioned on an outer surface ofthe guide wire.

Method 1200 may also include determining a location of one or moremicro-channels in the occlusion based on the depth-resolved opticaldata. The micro-channels may be as small as 50 μm in diameter. Once thelocation of one or more of these micro-channels is established, theguide wire may be controlled to traverse the occlusion based on thelocation of the one or more micro-channels. For example, the presence ofmicro-channels may indicate a structural weakness in the occlusion andcould identify a path of lower resistance for boring through theocclusion with the guide wire.

Example Computer System Embodiment

Various processing methods and other embodiments described thus far canbe implemented, for example, using one or more well-known computersystems, such as computer system 1300 shown in FIG. 13. In anembodiment, computer system 1300 may be an example of processing device108 illustrated in FIG. 1.

Computer system 1300 includes one or more processors (also calledcentral processing units, or CPUs), such as a processor 1304. Processor1304 is connected to a communication infrastructure or bus 1306. In oneembodiment, processor 1304 represents a field programmable gate array(FPGA). In another example, processor 1304 is a digital signal processor(DSP).

One or more processors 1304 may each be a graphics processing unit(GPU). In an embodiment, a GPU is a processor that is a specializedelectronic circuit designed to rapidly process mathematically intensiveapplications on electronic devices. The GPU may have a highly parallelstructure that is efficient for parallel processing of large blocks ofdata, such as mathematically intensive data common to computer graphicsapplications, images and videos.

Computer system 1300 also includes user input/output device(s) 1303,such as monitors, keyboards, pointing devices, etc., which communicatewith communication infrastructure 1306 through user input/outputinterface(s) 1302.

Computer system 1300 also includes a main or primary memory 1308, suchas random access memory (RAM). Main memory 1308 may include one or morelevels of cache. Main memory 1308 has stored therein control logic(i.e., computer software) and/or data.

Computer system 1300 may also include one or more secondary storagedevices or memory 1310. Secondary memory 1310 may include, for example,a hard disk drive 1312 and/or a removable storage device or drive 1314.Removable storage drive 1314 may be a floppy disk drive, a magnetic tapedrive, a compact disc drive, an optical storage device, tape backupdevice, and/or any other storage device/drive.

Removable storage drive 1314 may interact with a removable storage unit1318. Removable storage unit 1318 includes a computer usable or readablestorage device having stored thereon computer software (control logic)and/or data. Removable storage unit 1318 may be a floppy disk, magnetictape, compact disc, Digital Versatile Disc (DVD), optical storage disk,and/ any other computer data storage device. Removable storage drive1314 reads from and/or writes to removable storage unit 1318 in awell-known manner.

Secondary memory 1310 may include other means, instrumentalities, orapproaches for allowing computer programs and/or other instructionsand/or data to be accessed by computer system 1300. Such means,instrumentalities or other approaches may include, for example, aremovable storage unit 1322 and an interface 1320. Examples of theremovable storage unit 1322 and the interface 1320 may include a programcartridge and cartridge interface (such as that found in video gamedevices), a removable memory chip (such as an EPROM or PROM) andassociated socket, a memory stick and universal serial bus (USB) port, amemory card and associated memory card slot, and/or any other removablestorage unit and associated interface.

Computer system 1300 may further include a communication or networkinterface 1324. Communication interface 1324 enables computer system1300 to communicate and interact with any combination of remote devices,remote networks, remote entities, etc. (individually and collectivelyreferenced by reference number 1328). For example, communicationinterface 1324 may allow computer system 1300 to communicate with remotedevices 1328 over communications path 1326, which may be wired and/orwireless, and which may include any combination of local area networks(LANs), wide area networks (WANs), the Internet, etc. Control logicand/or data may be transmitted to and from computer system 1300 viacommunication path 1326.

In an embodiment, a tangible apparatus or article of manufacturecomprising a tangible computer useable or readable medium having controllogic (software) stored thereon is also referred to herein as a computerprogram product or program storage device. This includes, but is notlimited to, computer system 1300, main memory 1308, secondary memory1310, and removable storage units 1318 and 1322, as well as tangiblearticles of manufacture embodying any combination of the foregoing. Suchcontrol logic, when executed by one or more data processing devices(such as computer system 1300), causes such data processing devices tooperate as described herein.

Based on the teachings contained in this disclosure, it will be apparentto persons skilled in the relevant art(s) how to make and use theinvention using data processing devices, computer systems and/orcomputer architectures other than that shown in FIG. 13. In particular,embodiments may operate with software, hardware, and/or operating systemimplementations other than those described herein.

It is to be appreciated that the Detailed Description section, and notthe Summary and Abstract sections, is intended to be used to interpretthe claims. The Summary and Abstract sections may set forth one or morebut not all exemplary embodiments of the present invention ascontemplated by the inventor(s), and thus, are not intended to limit thepresent invention and the appended claims in any way.

Embodiments of the present invention have been described above with theaid of functional building blocks illustrating the implementation ofspecified functions and relationships thereof. The boundaries of thesefunctional building blocks have been arbitrarily defined herein for theconvenience of the description. Alternate boundaries can be defined solong as the specified functions and relationships thereof areappropriately performed.

The foregoing description of the specific embodiments will so fullyreveal the general nature of the invention that others can, by applyingknowledge within the skill of the art, readily modify and/or adapt forvarious applications such specific embodiments, without undueexperimentation, without departing from the general concept of thepresent invention. Therefore, such adaptations and modifications areintended to be within the meaning and range of equivalents of thedisclosed embodiments, based on the teaching and guidance presentedherein. It is to be understood that the phraseology or terminologyherein is for the purpose of description and not of limitation, suchthat the terminology or phraseology of the present specification is tobe interpreted by the skilled artisan in light of the teachings andguidance.

The breadth and scope of the present invention should not be limited byany of the above-described exemplary embodiments, but should be definedonly in accordance with the following claims and their equivalents.

What is claimed is:
 1. A catheter, comprising: a distal section, whereinthe distal section substantially surrounds a guide wire, and comprising:a plurality of waveguides patterned upon a flexible substrate, whereinat least one of the plurality of waveguides is configured to transmitone or more beams of radiation away from the distal section of thecatheter and at least one of the plurality of waveguides is configuredto receive one or more beams of scattered radiation that have beenreflected or scattered from a sample, and one or more optical elementsconfigured to at least one of focus and steer the one or more beams ofradiation; a proximal section, comprising: an optical source configuredto generate a source beam of radiation, and a detector configured togenerate depth-resolved optical data associated with the one or morebeams of scattered radiation; and a multiplexer configured to generatethe one or more beams of exposure radiation from the source beam ofradiation.
 2. The catheter of claim 1, wherein the multiplexer isprovided on the flexible substrate.
 3. The catheter of claim 2, whereinthe multiplexer is a passive element.
 4. The catheter of claim 2,wherein the multiplexer is electrically driven.
 5. The catheter of claim1, wherein the flexible substrate is folded into an annulus shape. 6.The catheter of claim 5, wherein the one or more optical elements arearranged such that the one or more optical elements substantially alignwith corresponding waveguides of the plurality of waveguides.
 7. Thecatheter of claim 1, further comprising an optical fiber configured toguide the source beam of radiation to the distal section.
 8. Thecatheter of claim 1, further comprising a plurality of optical fibersconfigured to guide a plurality of beams of radiation to the distalsection.
 9. The catheter of claim 1, further comprising a processingunit configured to: receive the depth-resolved optical data, andgenerate an image of the sample based on the depth-resolved opticaldata.
 10. The catheter of claim 1, wherein at least one of the one ormore optical elements includes a graded refractive index (GRIN) lens.11. The catheter of claim 1, wherein the plurality of waveguides areconfigured such that at least one of the plurality of waveguidestransmits radiation at a non-zero angle relative to an axis extendingalong a length of the guide wire and passing through a center of theguide wire.
 12. The catheter of claim 1, wherein the plurality ofwaveguides are configured such that at least one of the one or morebeams of radiation is directed substantially parallel to an axisextending along a length of the guide wire and passing through a centerof the guide wire.
 13. The catheter of claim 1, wherein the plurality ofwaveguides are spaced from each other by about 50 microns on theflexible substrate.
 14. The catheter of claim 1, further comprising anactuator configured to rotate the distal section about an axis extendingalong a length of the guide wire and passing through a center of theguide wire.
 15. The catheter of claim 14, further comprising a straingauge configured to monitor strain induced upon the distal section fromthe rotation.
 16. A guide wire, comprising: at least one optical fiberconfigured to transmit a source beam of radiation; a flexible substratecomprising a plurality of waveguides, wherein at least one of theplurality of waveguides is configured to transmit one or more beams ofradiation away from the guide wire and at least one of the plurality ofwaveguides is configured to receive one or more beams of scatteredradiation that have been reflected or scattered from a sample; amultiplexer configured to generate the one or more beams of radiationfrom the source beam of radiation; and one or more optical elementsconfigured to at least one of focus and steer the one or more beams ofradiation.
 17. The guide wire of claim 16, wherein the multiplexer isprovided on the flexible substrate.
 18. The guide wire of claim 16,wherein a distal end of the guide wire includes one or more cuttinglips.
 19. The guide wire of claim 16, wherein a distal end of the guidewire has a conical shape.
 20. The guide wire of claim 16, wherein themultiplexer is a passive element.
 21. The guide wire of claim 16,wherein the multiplexer is electrically driven.
 22. The guide wire ofclaim 16, wherein at least one of the one or more optical elementsincludes a graded refractive index (GRIN) lens.
 23. The guide wire ofclaim 16, wherein the plurality waveguides are configured such that atleast one of the one or more beams of radiation is transmittedsubstantially parallel to an axis extending along a length of the guidewire and passing through a center of the guide wire.
 24. The guide wireof claim 23, wherein the plurality of waveguides are spaced from eachother by about 50 microns on the flexible substrate.
 25. The guide wireof claim 23, wherein the at least one of the one or more beams ofradiation is transmitted through an opening at a tip of a distal end ofthe guide wire.
 26. The guide wire of claim 23, further comprising areflecting element, wherein at least one of the plurality of waveguidesis configured to transmit a beam of radiation in a direction of thereflecting element.
 27. The guide wire of claim 26, wherein thereflecting element is configured to transmit the beam of radiation at anon-zero angle with respect to the axis and away from the guide wire.28. The guide wire of claim 26, wherein the reflecting element isconfigured to transmit the beam of radiation at a 90 degree angle withrespect to the axis and away from the guide wire.
 29. The guide wire ofclaim 26, wherein the reflecting element is a spherical reflector. 30.The guide wire of claim 16, further comprising an actuator configured torotate the guide wire about an axis extending along a length of theguide wire and passing through a center of the guide wire.
 31. The guidewire of claim 30, further comprising a strain gauge configured tomonitor strain induced upon the guide wire from the rotation.
 32. Amethod for crossing an occlusion within an artery, comprising:transmitting one or more beams of radiation via one or more waveguideson a flexible substrate within a guide wire; receiving one or more beamsof scattered or reflected radiation from a sample; generating, using aprocessing device, depth-resolved optical data of the sample based onthe received one or more beams of scattered or reflected radiation;determining at least one of a distance between the guide wire and a wallof the artery and a distance between the guide wire and an occlusionwithin the artery based on the depth-resolved optical data; andcontrolling a position of the guide wire within the artery based on thedetermined distance or distances.
 33. The method of claim 32, furthercomprising generating an image of the sample based on the depth-resolvedoptical data and providing the image to the user via a user interface.34. The method of claim 32, further comprising traversing the occlusionwith the guide wire.
 35. The method of claim 34, wherein the traversingcomprises cutting at least a portion of the occlusion using one or morecutting lips disposed on a distal end of the guide wire.
 36. The methodof claim 34, wherein the traversing comprises heating at least a portionof the occlusion using a beam of radiation.
 37. The method of claim 32,wherein the controlling a position comprises controlling a position ofthe guide wire to be substantially in a center of the artery as theguide wire moves along a length of the artery.
 38. The method of claim32, further comprising determining a location of one or moremicro-channels in the occlusion based on the depth-resolved opticaldata.
 39. The method of claim 38, wherein the controlling comprisestraversing the occlusion with the guide wire based on the location ofthe one or more micro-channels.